Director, Global Regulatory Affairs

Job Description

Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, Rockville Vaccines, Waltham Posted Date: Feb 4 2025 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. Are you passionate about regulatory strategy and oncology Within the Oncology space, we are in a period of very dynamic growth, as we continue to expand and develop our pipeline and portfolio. We are looking for a driven and motivated Global Regulatory Affairs Director who will be instrumental in developing and executing global and regional regulatory strategies for assigned assets in our growing oncology portfolio. Your efforts will ensure compliance with regulatory requirements while optimising the development programme to meet the needs of patients in global markets. Key responsibilities will be focused on the development of appropriate regional regulatory strategy(ies) and for delivery of the Global Regulatory Strategy. Activities may include Health Authority submissions and approvals, for example, Clinical Trial Applications and licence applications. The role requires representing GSK with the regional Health Authority/Authorities. In addition, this role will have extensive matrix working within cross-functional teams, as well as with GSK affiliates globally. You will work with the Clinical Development Team and with the global regulatory and regional teams, to ensure a robust regulatory strategy is in place to support the timely submission and approval of regulatory submissions in key markets. In this role you will Strategic Development: Act as the Global Regulatory Lead (GRL), or collaborate as a regional lead with the GRL, and Global Regulatory Therapeutic Area (TA) Head to develop and implement robust regional regulatory strategies that align with the Medicines Development Strategy and Integrated Asset Plan. Matrix Leadership: Engage in extensive matrix working within GSK, including with senior management, and represent GSK with local regulatory agencies to secure optimal labelling based on available data. Global Collaboration: Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals. Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle. Regulatory Intelligence: Conduct regulatory intelligence activities to assess the competitive landscape and its impact on regulatory strategies. Why you Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in biological or healthcare science Minimum of 5+ years of experience in pharmaceutical industry Regulatory Affairs Minimum of 2 years of experience in Oncology Capable of leading development, submission and approval activities in different region(s) globally Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Advanced Scientific Degree (PhD, MD, PharmD). Experience with all phases of the drug development process in regulatory affairs. Awareness of global regulatory processes, including submission and approval activities. Understanding of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally. Strong matrix working skills with the ability to facilitate dialogue and contribute to strategic changes. Creative problem-solving abilities with a balanced approach to regulatory expectations and compliance. Knowledge of relevant therapy area and the ability to further develop necessary specialist knowledge for the product or area of medicine Ability to coach and mentor others #LI-GSK The annual base salary for new hires in this position ranges from $166,500 to $277,500 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. 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